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Clinical Trials/NCT05545488
NCT05545488
Completed
Not Applicable

Examining the Effect of Virtual Reality on Pain and Anxiety Management During Pelvic Examination

Istanbul University - Cerrahpasa (IUC)1 site in 1 country128 target enrollmentDecember 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Examination,Virtual Reality
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
128
Locations
1
Primary Endpoint
Pain level
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Objective: The study was conducted as a randomized controlled experimental study to examine the effect of the video watched with virtual reality glasses during the pelvic examination on the level of pain and anxiety perceived by women.

Materials-Methods: The sample of the study consisted of 128 women (64 experimental, 64 control group) who applied to the Obstetrics and Gynecology Polyclinics with non-pregnancy complaints between November 2021 and February 2022, volunteered to participate in the study and were approved by the doctor for pelvic examination. Institutional and ethical committee permissions were obtained before starting the study. Descriptive Information Form, State Anxiety Scale, Visual Comparison Scale (GDS), Pelvic Examination Experience Evaluation Questionnaire, and Questionnaire Evaluating Non-Verbal Responses to Emotional Stressful Situations, prepared by the researcher, were used to collect data. In the pre-test to the women in the experimental group of the study: Descriptive Information Form, State Anxiety Scale, Visual Comparison Scale (for anxiety), then Pelvic examination + Virtual reality application (using virtual reality glasses for a minimum of 5 maximum 15 minutes), Emotional Stress to be applied by the researcher The Form Evaluating Non-Verbal Responses to the Creating Situations, and in the post-test: State Anxiety Scale, Visual Comparison Scale (anxiety + pain), Pelvic Examination Experience Evaluation Questionnaire were applied. In the pre-test to the women in the control group of the study: Introductory Information Form, State Anxiety Scale, Visual Comparison Scale (for anxiety), then Pelvic examination (routine service), Form Evaluating Non-Verbal Responses to Emotional Stressing Situations to be administered by the Researcher, In the post-test: State Anxiety Scale, Visual Comparison Scale (anxiety + pain), Pelvic Examination Experience Evaluation Questionnaire were applied. Data were evaluated in computer environment and using SPSS 23.0 statistical package program. A p value of <.05 for the data was considered statistically significant.

Registry
clinicaltrials.gov
Start Date
December 15, 2021
End Date
March 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Gülay KURT

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

Inclusion Criteria

  • Being between the ages of 18-40
  • Being able to read and write
  • To be competent to express oneself
  • Having applied to the outpatient clinic for any gynecological complaint (bleeding, menstrual cycle irregularity, discharge, itching...) or for routine gynecological control.

Exclusion Criteria

  • Having a current pregnancy
  • Complaining of acute pelvic pain
  • Having any damage or lesion in the perineum that may cause pain during the examination
  • Having used a pharmacological agent or method with analgesic or anxiolytic effect 24 hours before the examination
  • Having a vaginismus problem
  • Having any physical or mental problems that may prevent communication

Outcomes

Primary Outcomes

Pain level

Time Frame: 15 minutes

The visual comparison scale,(VAS).The visual analog scale has a score from 1 to 10. The higher the score, the higher the pain intensity.

Anxiety level

Time Frame: 15 minutes

The visual comparison scale and the state anxiety scale were evaluated.(VAS).The visual analog scale has a score from 1 to 10. The higher the score, the higher the pain intensity. State Anxiety Scale(STAI FORM TX - I) It is an inventory in which state anxiety is evaluated. The scores vary between 20 and 80 points. With the increase in the score, the level of anxiety also increases.

Pelvic examination using virtual reality glasses

Time Frame: 15 minutes

Before the video, anxiety is evaluated with a visual comparison scale, then videos with nature, rain, water, flower scenes are watched for 5 to 15 minutes by wearing virtual reality glasses. Afterwards, anxiety and pain are evaluated with state anxiety scale and visual comparison scale. All results SPSS 23.0 It is analyzed by the program.

Study Sites (1)

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